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BREXIT: What happens now?

December 2019 – January 2020: Parliament votes on Boris Johnson’s Brexit deal. During Christmas period the UK MPs will be called back to discuss to pass legislation – Boris Johnson’s Brexit deal –  in the form of the Withdrawal Agreement Bill allowing to meet the January 31st deadline to take the UK out of the…
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Is the Irish health sector prepared for an eventual Brexit?

If you are an Irish undertaking producing or exporting medical devices into the European Union or you are simply willing to extend your market, this article is for you. It is a fact that the Irish Health Products Regulatory Authority is in close cooperation with its correlative Department of Health to plan, alongside stakeholders from…
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Spain is ready for Brexit: new checklist for Medical Devices and Cosmetics

The Spanish Agency of Medicines and Medical Devices (AEMPS) has published a Checklist to verify the Brexit readiness of companies based in Spain in the sector of: Medical Devices: Devices with a Notified Body (NB) established in the UK: manufacturer must ask for a new Certificate from a EU27 NB or for the transferal of…
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Brexit & EU product legislation: What to expect?

Undoubtedly, the departure of the UK from the European Union (EU) will cause a major shift in the industry sector and the related EU product legislation. On 19th January 2018, the European Commission published an official Notice to Stakeholders [Withdrawal of the United Kingdom and EU rules on company law] presenting the new rules on…
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How will cosmetic products be regulated in the UK in case of a no-deal Brexit?

Preparing for different Brexit scenarios, the UK government published a guidance covering the EU Exit Regulation for Cosmetic Products in case UK leaves the European Union without a deal. While there are many similarities between the EU and UK regulatory regime for cosmetic products, the withdrawal of the UK from the European Union without a…
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Update on Brexit: Cosmetics

On the 18th of July, the European Commission published a Notice to stakeholders regarding the withdrawal of the United Kingdom and the impact on the EU rules in the field of cosmetic products. Consequences for cosmetic products As of the withdrawal date, which is set so far for the 1st of November 2019, the UK…
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Brexit preparedness in case of a no-deal scenario

With only 8 weeks remaining, European authorities are finalizing preparations for the withdrawal of the United Kingdom from the European Union. Considering the approaching deadline, the European Commission has published its 6th Brexit preparedness communication. The European Commission sends a strong message to all stakeholders including those in the medical device industry to prepare for…
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UK Government publishes EU Exit Regulation for Medical Devices

As the UK is preparing its withdrawal from the European Union, EU law is currently being converted into a new type of domestic (UK) law. The type of law that will become effective in the UK on the exit day, currently scheduled on October 31st2019, is called “retained EU law”. By removal of the constitutional…
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MHRA Official Guidance on How Medicines, Medical Devices and Clinical Trials Would Be Regulated If There’s No Brexit Deal

March 29th 2019 is fast approaching, and the UK is  currently facing to leave the EU without a deal in place. For this  reason, the UK government has been publishing technical notices for  businesses and citizens to understand what to expect in a no deal  scenario. We will focus on the recently published MHRA official…
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Official EU Notice on BREXIT

On November 29th 2018, the European Commission (Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs) published an official notice to stakeholders in reference to NEW EU rules in the field of cosmetic products in relations to the Withdrawal of the United Kingdom from the European Union. Download Official Notice – Click Here Why now? In…
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